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(Circulation. 2003;108:788.)
© 2003 American Heart Association, Inc.
Clinical Investigation and Reports |
From Ospedale San Raffaele, Milano, Italy (A.C.); PSK No 7 Zaklad Kardiologii, Katowice, Poland (J.D.); John Radcliffe Hospital, Oxford, Great Britain (A.B.); Krankenhaus Siegburg, Siegburg, Germany (E.G.); Krankenhaus der Barmherzigen Brüder, Trier, Germany (K.H.); Internistische Klinik Dr. Müller, Munich, Germany (S.S.); Jagiellonian University, Krakow, Poland (D.D.); Sunnybrook & Womens College Health Sciences Center, Toronto, Canada (S.F.); Centre Hospitalier Universitaire Jean Minjoz, Besancon ,France (F.S.); Jan Pawel II Hospital, International Cardiology Clinic, Krakow, Poland (K.Z.); Ospedali Riuniti di Bergamo, Bergamo, Italy (G.G.); and Boston Scientific Corporation, Natick, Mass (M.E.R.).
Correspondence to Antonio Colombo, MD, Director, Cardiac Catheterization Laboratory, EMO Centro Cuore Columbus S.r.l., Sede Operativa c/o Casa Cura Columbus, Via M. Buonarroti, 48 20145 Milano, Italy. E-mail colombo{at}emocolumbus.it
Received June 18, 2003; revision received July 8, 2003; accepted July 8, 2003.
| Abstract |
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Methods and Results We conducted a randomized, double-blind trial of 536 patients at 38 medical centers evaluating slow-release (SR) and moderate-release (MR) formulations of a polymer-based paclitaxel-eluting stent (TAXUS) for revascularization of single, primary lesions in native coronary arteries. Cohort I compared TAXUS-SR with control stents, and Cohort II compared TAXUS-MR with a second control group. The primary end point was 6-month percent in-stent net volume obstruction measured by intravascular ultrasound. Secondary end points were 6-month angiographic restenosis and 6- and 12-month incidence of major adverse cardiac events, a composite of cardiac death, myocardial infarction, and repeat revascularization. At 6 months, percent net volume obstruction within the stent was significantly lower for TAXUS stents (7.9% SR and 7.8% MR) than for respective controls (23.2% and 20.5%; P<0.0001 for both). This corresponded with a reduction in angiographic restenosis from 17.9% to 2.3% in the SR cohort (P<0.0001) and from 20.2% to 4.7% in the MR cohort (P=0.0002). The incidence of major adverse cardiac events at 12 months was significantly lower (P=0.0192) in the TAXUS-SR (10.9%) and TAXUS-MR (9.9%) groups than in controls (22.0% and 21.4%, respectively), predominantly because of a significant reduction in repeat revascularization of the target lesion in TAXUS-treated patients.
Conclusions Compared with a bare metal stent, paclitaxel-eluting stents reduced in-stent neointimal formation and restenosis and improved 12-month clinical outcome of patients with single de novo coronary lesions.
Key Words: coronary disease drugs stents restenosis
| Introduction |
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| Methods |
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Eligible patients had stable or unstable angina or silent ischemia, were at least 18 years of age, and were acceptable candidates for percutaneous coronary intervention or CABG. Angiographic inclusion criteria specified a single de novo target lesion with estimated stenosis
50% and
99%, estimated length
12 mm, and location in a native coronary vessel
3.0 mm and
3.5 mm in diameter. Exclusion criteria included recent coronary intervention (
30 days), left ventricular ejection fraction <30%, evolving myocardial infarction (MI), unprotected left main coronary disease, or prespecified need to implant more than one 15-mm stent for full lesion coverage.
Polymer-Based Paclitaxel-Eluting Stent
The TAXUS stent was a slotted-tube stainless steel stent (NIR, Medinol Ltd) coated with a proprietary polymer (Translute) designed to control paclitaxel release with an initial burst phase over the first 48 hours after implantation followed by a low-level release phase for
10 days.4 Paclitaxel-eluting stents were coated with a total loaded dose of 1 µg/mm2. Two paclitaxel-eluting release formulations were evaluated, TAXUS-SR (slow release) and TAXUS-MR (moderate release), which has an 8-fold higher 10-day drug release. Of the total loaded dose, approximately 90% remains sequestered within the SR polymer formulation and 75% within the MR formulations without further measurable paclitaxel release. The control stent was the uncoated NIR stent. Study stents included diameters of 3.0 and 3.5 mm and 15-mm length, premounted on 20-mm balloon delivery catheters.
Study Procedures
A first cohort of patients was randomized to TAXUS-SR or control. After clearance by a data monitoring committee, a second cohort of patients was randomized to TAXUS-MR or control.
To maintain blinding, TAXUS and control stents were indistinguishable by physical and radiographic appearance. The intravascular ultrasound (IVUS) and quantitative coronary angiography (QCA) core laboratories and the independent Clinical Events Committee were blinded to treatment allocation.
Twenty-four hours before catheterization or, alternatively, at least 4 hours before placement of the randomly assigned stents, patients received 300 mg of clopidogrel (unless treatment was initiated previously) and 75 mg of aspirin. Patients meeting angiographic inclusion criteria were randomized and treated in accordance with standard interventional techniques. Heparin was administered to maintain an activated clotting time
250 seconds during the procedure. Use of additional stents was permitted if patency of the stented vessel was compromised. Second stents were of the same type as those originally assigned. Third stents, if necessary, could be of any type considered appropriate by the investigator, except for study stents. After stent placement, patients received clopidogrel 75 mg/d (or ticlopidine 250 mg twice daily) for at least 6 months and aspirin 75 mg/d, maintained indefinitely.
Follow-Up
Clinical status was assessed at hospital discharge and 1, 6, and 12 months after the procedure. The patients will be followed up annually to year 5. These results will be presented in future reports. IVUS and QCA assessments were performed after the procedure and at 6-month follow-up as described previously.2
IVUS and QCA
Quantitative IVUS and angiography analyses (QCA) were performed by a core laboratory (Cardialysis BV, Rotterdam, the Netherlands) according to established methodology.5,6 IVUS analysis presented in the present report was performed within the stented segment. QCA was performed within the stented segment and the total analysis segment. The total analysis segment was defined as the stented segment plus the regions 5 mm proximal and distal to the stent. In-stent analysis included the length of all stents used to treat the target lesion during the procedure. Incomplete stent apposition was identified by IVUS and defined as separation of 1 or more stent struts from the vessel wall with evidence of blood flow behind the strut.
Study End Points
The primary end point was the percent of the stent volume obstructed by neointimal proliferation measured by IVUS at 6 months. Secondary end points included major adverse cardiac events (MACE), including cardiac death, Q-wave MI, non-Q-wave MI, and target-vessel revascularization at 1, 6, and 12 months. Non-Q-wave MI was defined as elevation of creatine kinase levels >2 times normal with detectable creatine kinase-MB in the absence of pathological Q-waves. Target-vessel revascularization included all CABG and percutaneous coronary intervention performed on the target vessel. Target lesion revascularization was performed to treat restenosis of the analysis segment (stent plus the 5-mm regions from the stent border). QCA measurements at 6 months included binary restenosis (defined as
50% diameter stenosis), reference vessel diameter, minimum lumen diameter, percent diameter stenosis, and late lumen loss.
An independent clinical events committee adjudicated MACE. An independent data monitoring committee reviewed data for potential safety concerns.
Statistical Analysis
The primary study hypothesis was that paclitaxel elution would diminish in-stent net volume obstruction at 6 months compared with bare control stents. A mean net volume obstruction of 26±17% was estimated for the uncoated control stent.7 To obtain 80% power to detect an absolute difference of 25% between treatment groups within each cohort with a 35% 6-month attrition rate for IVUS, 133 patients per group were required. This sample size was calculated for a 2-group t test of equal means. Safety and efficacy variables were analyzed for intention-to-treat populations. TAXUS-SR and TAXUS-MR cohorts were compared with their respective controls. Continuous variables are expressed as mean±SD and compared with 2-tailed probability values from an overall F test from a 1-way ANOVA and pairwise comparisons with Fishers test of least significant difference. Discrete variables are displayed as percentages and evaluated with 2-tailed probability values from Fishers exact test, overall and pairwise. Kaplan-Meier estimates were compared by the Wilcoxon test. A probability value of less than 0.05 was considered statistically significant.
| Results |
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Procedural Characteristics
Baseline lesion characteristics were comparable among all groups (Table 1). Clinical procedural success rates, defined as achievement of an in-lesion diameter stenosis <30% of the target lesion without the occurrence of in-hospital MACE, were comparable between cohorts and between treatment and control arms (TAXUS-SR 95%; SR control 93%; TAXUS-MR 96%; MR control 94%). Use of single or double study stents and implanted stent sizes were also similar among all groups. One study stent was implanted in 93% of TAXUS-SR patients and in 94% of SR controls, TAXUS-MR patients, and MR controls. Furthermore, the groups did not differ with regard to use of glycoprotein IIb/IIIa inhibitors (TAXUS-SR 11.5% versus SR controls 12.5%; TAXUS-MR 20.7% versus MR controls 23.9%).
Primary End Point
IVUS imaging for the primary end point, percent in-stent net volume obstruction at 6 months, was available for 91% and 88% of patients in the SR and MR cohorts 6 months after the procedure, respectively. As shown in Table 2, the primary end point was met with a significant reduction in percent in-stent net volume obstruction at 6 months in the TAXUS-SR (7.8% versus 23.2%; P<0.0001) and TAXUS-MR (7.8% versus 20.5%; P<0.0001) groups compared with their respective control groups.
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Coronary Angiography
Six-month coronary angiography was performed in 98% and 96% of all patients in the SR and MR cohorts, respectively. Compared with control, 6-month angiographic parameters (Table 2) were significantly improved in the TAXUS groups, with larger minimum lumen diameter, lower percent diameter stenosis, and reduced late loss. This translated into a significant improvement in binary restenosis rates in the total analysis segment for the TAXUS groups, with reductions from 20.1% to 5.5% in the SR cohort (P=0.0004) and from 23.8% to 8.6% in the MR cohort (P=0.001). Among the 18 restenoses identified in TAXUS patients, 5 occurred in adjacent bare metal, nonstudy stents (1 in SR, 4 in MR).
As shown in Table 3, reductions in late loss extended beyond the stented segment to the 5 mm proximal and distal to the stent edges, with significantly lower late loss at the edges in both the TAXUS-SR and TAXUS-MR stents than in the control stents. In total, 8 aneurysms were identified by QCA in this study (3 in the TAXUS-SR group, 1 in the SR control group, 1 in the TAXUS-MR group, and 3 in the MR control group). Differences in aneurysm rates between TAXUS and control groups were not significant, and aneurysm formation was not correlated with clinical adverse events.
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Intravascular Ultrasound
IVUS was also used to assess vessel, stent, and lumen volume and the presence of incomplete apposition of stent struts after stent implantation and at 6 months. As shown in Table 2, vessel volume within the stented segment and stent volume were not different between the TAXUS-SR and -MR groups and their respective controls either at baseline or at 6-month follow-up. Lumen volume was also comparable between groups within each cohort at baseline. However, at follow-up, the lumen area was significantly larger in the TAXUS-SR and TAXUS-MR groups than in their respective controls (P=0.0002 and 0.0004).
The incidence of incomplete apposition did not differ between groups in either cohort at baseline (TAXUS-SR 11.1% versus SR control 9.3%, P=0.68; TAXUS-MR 3.1% versus MR control 7.9%, P=0.10) or at 6 months (TAXUS-SR 12.5% versus SR control 7.9%, P=0.29; TAXUS-MR 9.9% versus MR control 9.2%, P=1.00).
Major Adverse Cardiac Events
Periprocedural and in-hospital MACE rates were comparable in all groups, without significant differences (TAXUS-SR 1.5% versus SR control 4.4%; TAXUS-MR 2.2% versus MR control 4.5%). There was 1 in-hospital death related to periprocedural retroperitoneal bleeding and multiple organ failure and 1 Q-wave MI, both in control patients. One periprocedural stent thrombosis occurred in a TAXUS-SR patient. Thirty-day MACE rates were low and comparable among groups (2.3% TAXUS-SR versus 4.4% SR control and 2.2% TAXUS-MR versus 4.5% MR control), with non-Q-wave MIs being the dominant events.
Clinical follow-up at 6 and 12 months (shown in Table 4) was available for 99% and 96% of all patients in the SR and MR cohorts, respectively. At 6 months, MACE rates were significantly lower for TAXUS-SR (8.5%) and for TAXUS-MR (7.8%) than for their respective control groups (19.5%, P=0.01 and 20.0%, P=0.006, respectively). This reduction in MACE was attributable to lower rates of target-lesion revascularization in the TAXUS groups (4.6% SR, 3.1% MR) than in the control groups (12.0% and 14.6%). This clinical benefit was maintained at 12 months, with lower target-lesion revascularization rates in the TAXUS groups (4.7% SR and 3.8% MR) than in the control groups (12.9% and 16.0%). This translated into 12-month MACE rates of 10.9% for TAXUS-SR (P=0.02) and 9.9% for TAXUS-MR (P=0.02) compared with 22.0% and 21.4% for the corresponding control groups.
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Two patients treated with TAXUS stents (1 SR and 1 MR) presented with ST-elevation MIs between 6 and 12 months. Subsequent angiography after treatment with thrombolytic therapy revealed widely patent study stents. Because of the absence of other explanatory coronary stenoses, these were adjudicated as "presumed stent thromboses" that accounted for the late stent thrombosis rate of 0.7%.
As shown in the Figure, MACE-free survival at 6 months in the TAXUS-SR (93.9%) and TAXUS-MR (93.3%) groups was significantly higher than in their respective controls (86.0% and 83.6%). This benefit was sustained up to 12 months, with a MACE-free survival rate of 89.2% in the TAXUS-SR group and 89.5% in the TAXUS-MR group compared with 78.7% (P=0.01) and 79.1% (P=0.008) in their respective control groups.
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| Discussion |
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These beneficial antirestenotic effects are balanced against concerns about potential vascular cytotoxicity and its associated clinical correlates. First, discontinuation of thienopyridine after 6 months was not associated with a significant increase in late stent thrombosis rates in TAXUS compared with control. The rate of 0.7% was comparable to the 0.76% reported by Uretsky and coauthors8 for bare metal stents. Second, angiographic evaluation of the stent edges showed that the beneficial effect of TAXUS within the stent was associated with low rates of edge stenosis comparable to control stents, which eliminates concern about aggravated edge stenosis. In fact, the QCA measurements showed that late lumen loss at the proximal and distal edges was significantly lower in both TAXUS groups than in their controls. Third, use of paclitaxel-eluting stents was not associated with an increased incidence of incomplete stent apposition at baseline or at follow-up. Fourth, rates of aneurysm were comparable between TAXUS and control stents. Taken together, the improvements in restenosis are accompanied by an acceptable safety profile.
These findings contrast with other studies assessing the effects of local paclitaxel delivery that used different doses and delivery systems. High-capacity delivery (up to 4000 µg) of a paclitaxel derivative through 4 or 5 high-capacity acrylate polymer sleeves for up to 6 months (Quanam QuaDDS stent system) was associated with an increased incidence of acute, subacute, and late stent thrombosis (SCORE trial).9 Paclitaxel delivery with non-polymer-based delivery systems resulted in a significant reduction in neointimal formation; however, angiographic improvements did not translate into clinical benefit.10 With the TAXUS system, biphasic, polymer-controlled delivery of low concentrations of paclitaxel resulted in significant reductions in neointimal proliferation that translated into clinical benefit. Persistence of these benefits in incidence of MACE and target-lesion revascularization from 6 to 12 months indicates that polymer-based paclitaxel-eluting stents may indeed inhibit rather than merely delay restenosis. Of the 4 patients who required operative revascularization between 6 and 12 months, all had patent study stents with diffuse progression of the underlying arteriosclerosis outside the stent. One patient had restenosis proximal to the patent study stent but within the analysis segment.
The present findings are in line with recent reports on a stent system that used polymer-based delivery of sirolimus.11 Both stent systems provide significant reductions in in-stent neointimal hyperplasia, which translates into a reduced need for repeat interventions and a reduced incidence of MACE. One major differentiator between these 2 systems appears to be the amount of angiographic late loss seen 6 months after stent implantation. The 60% reduction in mean late loss at 6 months to 0.31 mm in TAXUS-SR and 0.30 mm in TAXUS-MR occurred without a shift toward negative late loss. These results are in contrast to findings with a sirolimus-eluting stent (RAVEL),11 in which a mean 6-month late loss of -0.01 mm was reported. A negative mean late loss suggests the presence of positive vascular remodeling with vessel distension in a subgroup of patients. Future studies will have to prospectively determine the optimum amount of late loss, combining sufficient antirestenotic properties and adequate healing after stent implantation.
TAXUS II suggests that TAXUS-SR is the minimum effective paclitaxel formulation for standard-risk, de novo lesions. The slow- and moderate-release formulations studied in TAXUS II are loaded with the same dose density of paclitaxel (85 µg per 15-mm stent). The major distinction between the 2 formulations is the 8-fold greater amount of drug released from the TAXUS-MR stent over 10 days, even though the total loaded dose is the same. This pharmacological difference did not translate into differences in IVUS, angiographic, or clinical outcomes given that the study was not designed to detect differences between formulations. The similar efficacy profiles of the 2 formulations may indicate that the dosing threshold to interrupt the restenotic cascade in low-risk lesions had been reached with the slow-release formulation. It is unclear, however, whether the same threshold applies for higher-risk patient populations (diabetic patients) or more complex lesions (small diameter, long lesions, or in-stent restenosis), where much of the unmet need currently lies.
Limitations of the present study evaluating polymer-based paclitaxel elution are the need for longer-term follow-up and the focus on standard-risk, focal, de novo lesions that may not reflect the more complex lesions and patients encountered in real-world practice. The next step in assessing the utility of this promising technology is to expand to studies in more challenging lesion sets and to evaluate optimum dosing strategies.
| Appendix |
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| Acknowledgments |
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| Footnotes |
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Dr Banning has received fees for speaking at interventional cardiology meetings. Dr Fort has received funds from Boston Scientific, the study sponsor and the manufacturer of the stents that are the subject of this article, to cover the costs of enrolling patients in this study; Dr Fort also has a preceptor role with Boston Scientific. Dr Russell is a full-time employee of Boston Scientific. Dr Guagliumi has a consultant agreement with Boston Scientific.
| References |
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2. Grube E, Silber S, Hauptmann KE, et al. TAXUS I: 6 and 12 month results from a randomized, double blind trial on a slow release paclitaxel eluting stent for de novo coronary lesions. Circulation. 2003; 107: 3842.
3. Tanabe K, Serruys PW, Grube E, et al. TAXUS III trial: in-stent restenosis treated with stent based delivery of paclitaxel incorporated in a slow release polymer formulation. Circulation. 2003; 107: 559564.
4. Silber S, Grube E. The Boston Scientific Antiproliferative, paclitaxel eluting stents (TAXUS). In: Serruys P, Kutryk M, eds. Handbook of Coronary Stents. 4th ed. London, UK: Martin Dunitz Publishers Ltd; 2001: 311319.
5. Serruys P, Foley DP, de Feyter PJ. Quantitative Coronary Angiography in Clinical Practice. Dordrecht, the Netherlands: Kluwer Academic; 1994.
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7. Costa MA, Sabate M, Kay IP, et al. Three-dimensional intravascular ultrasonic volumetric quantification of stent recoil and neointimal formation of two new generation tubular stents. Am J Cardiol. 2000; 85: 135139.[CrossRef][Medline] [Order article via Infotrieve]
8. Uretsky BF, Rosanio S, Lerakis S, et al. A prospective evaluation of angiography-guided coronary stent implantation with high versus very high balloon inflation pressure. Am Heart J. 2000; 140: 804812.[CrossRef][Medline] [Order article via Infotrieve]
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E. L. Hannan, M. Racz, D. R. Holmes, G. Walford, S. Sharma, S. Katz, R. H. Jones, and S. B. King III Comparison of Coronary Artery Stenting Outcomes in the Eras Before and After the Introduction of Drug-Eluting Stents Circulation, April 22, 2008; 117(16): 2071 - 2078. [Abstract] [Full Text] [PDF] |
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S. G Raja and G. D Dreyfus Current Status of Off-pump Coronary Artery Bypass Surgery Asian Cardiovasc Thorac Ann, April 1, 2008; 16(2): 164 - 178. [Abstract] [Full Text] [PDF] |
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E. L. Hannan, M. Racz, G. Walford, D. R. Holmes, R. H. Jones, S. Sharma, S. Katz, and S. B. King III Drug-Eluting Versus Bare-Metal Stents in the Treatment of Patients With ST-Segment Elevation Myocardial Infarction J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 129 - 135. [Abstract] [Full Text] [PDF] |
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J. Aoki, G. S. Mintz, N. J. Weissman, J. T. Mann, L. Cannon, J. Greenberg, E. Grube, A.R. Z. Masud, J. Koglin, L. Mandinov, et al. Chronic Arterial Responses to Overlapping Paclitaxel-Eluting Stents: Insights From Serial Intravascular Ultrasound Analyses in the TAXUS-V and -VI Trials J. Am. Coll. Cardiol. Intv., April 1, 2008; 1(2): 161 - 167. [Abstract] [Full Text] [PDF] |
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M. Billinger, J. Beutler, K. R. Taghetchian, A. Remondino, P. Wenaweser, S. Cook, M. Togni, C. Seiler, C. Stettler, F. R. Eberli, et al. Two-year clinical outcome after implantation of sirolimus-eluting and paclitaxel-eluting stents in diabetic patients Eur. Heart J., March 2, 2008; 29(6): 718 - 725. [Abstract] [Full Text] [PDF] |
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K. E. Kip, K. Hollabaugh, O. C. Marroquin, and D. O. Williams The Problem With Composite End Points in Cardiovascular Studies The Story of Major Adverse Cardiac Events and Percutaneous Coronary Intervention. J. Am. Coll. Cardiol., February 19, 2008; 51(7): 701 - 707. [Abstract] [Full Text] [PDF] |
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A. J. Kirtane, S. G. Ellis, K. D. Dawkins, A. Colombo, E. Grube, J. J. Popma, M. Fahy, M. B. Leon, J. W. Moses, R. Mehran, et al. Paclitaxel-Eluting Coronary Stents in Patients With Diabetes Mellitus Pooled Analysis From 5 Randomized Trials. J. Am. Coll. Cardiol., February 19, 2008; 51(7): 708 - 715. [Abstract] [Full Text] [PDF] |
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A. Jeremias and A. Kirtane Balancing Efficacy and Safety of Drug-Eluting Stents in Patients Undergoing Percutaneous Coronary Intervention Ann Intern Med, February 5, 2008; 148(3): 234 - 238. [Abstract] [Full Text] [PDF] |
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P. S. Teirstein Unprotected left main intervention patient selection, operator technique, and clinical outcomes. J. Am. Coll. Cardiol. Intv., February 1, 2008; 1(1): 5 - 13. [Abstract] [Full Text] [PDF] |
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J. Aoki, A. Kirtane, M. B. Leon, and G. Dangas Coronary artery aneurysms after drug-eluting stent implantation. J. Am. Coll. Cardiol. Intv., February 1, 2008; 1(1): 14 - 21. [Abstract] [Full Text] [PDF] |
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R. Rogacka, A. Chieffo, I. Michev, F. Airoldi, A. Latib, J. Cosgrave, M. Montorfano, M. Carlino, G. M. Sangiorgi, A. Castelli, et al. Dual antiplatelet therapy after percutaneous coronary intervention with stent implantation in patients taking chronic oral anticoagulation. J. Am. Coll. Cardiol. Intv., February 1, 2008; 1(1): 56 - 61. [Abstract] [Full Text] [PDF] |
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D. Mukherjee and D. J. Moliterno Effectiveness of Drug-Eluting Stents in Real-World Patients JAMA, January 30, 2008; 299(4): 454 - 455. [Full Text] [PDF] |
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E. L. Hannan, C. Wu, G. Walford, A. T. Culliford, J. P. Gold, C. R. Smith, R. S.D. Higgins, R. E. Carlson, and R. H. Jones Drug-Eluting Stents vs. Coronary-Artery Bypass Grafting in Multivessel Coronary Disease N. Engl. J. Med., January 24, 2008; 358(4): 331 - 341. [Abstract] [Full Text] [PDF] |
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O. C. Marroquin, F. Selzer, S. R. Mulukutla, D. O. Williams, H. A. Vlachos, R. L. Wilensky, J.-F. Tanguay, E. M. Holper, J. D. Abbott, J. S. Lee, et al. A Comparison of Bare-Metal and Drug-Eluting Stents for Off-Label Indications N. Engl. J. Med., January 24, 2008; 358(4): 342 - 352. [Abstract] [Full Text] [PDF] |
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American College of Cardiology/American Heart Asso, 2007 Writing Group to Review New Evidence and Upda, S. B. King III, S. C. Smith Jr, J. W. Hirshfeld Jr, A. K. Jacobs, D. A. Morrison, and D. O. Williams 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention J. Am. Coll. Cardiol., January 15, 2008; 51(2): 172 - 209. [Full Text] [PDF] |
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S. B. King III, S. C. Smith Jr, J. W. Hirshfeld Jr, A. K. Jacobs, D. A. Morrison, D. O. Williams, 2005 WRITING COMMITTEE MEMBERS, S. C. Smith Jr, T. E. Feldman, J. W. Hirshfeld Jr, et al. 2007 Focused Update of the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention: A Report of the American College of Cardiology/American Heart Association Task Force on Practice Guidelines: 2007 Writing Group to Review New Evidence and Update the ACC/AHA/SCAI 2005 Guideline Update for Percutaneous Coronary Intervention, Writing on Behalf of the 2005 Writing Committee Circulation, January 15, 2008; 117(2): 261 - 295. [Full Text] [PDF] |
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E. Grube, K. D. Dawkins, G. Guagliumi, A. P. Banning, K. Zmudka, A. Colombo, L. Thuesen, K. Hauptman, J. Marco, W. Wijns, et al. TAXUS VI 2-year follow-up: randomized comparison of polymer-based paclitaxel-eluting with bare metal stents for treatment of long, complex lesions Eur. Heart J., November 1, 2007; 28(21): 2578 - 2582. [Abstract] [Full Text] [PDF] |
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M.-C. Morice, P. W. Serruys, P. Barragan, C. Bode, G.-A. Van Es, H.-P. Stoll, D. Snead, L. Mauri, D. E. Cutlip, and E. Sousa Long-Term Clinical Outcomes With Sirolimus-Eluting Coronary Stents: Five-Year Results of the RAVEL Trial J. Am. Coll. Cardiol., October 2, 2007; 50(14): 1299 - 1304. [Abstract] [Full Text] [PDF] |
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C. A. Simonton, B. Brodie, B. Cheek, F. Krainin, C. Metzger, J. Hermiller, S. Juk, P. Duffy, A. Humphrey, M. Nussbaum, et al. Comparative Clinical Outcomes of Paclitaxel- and Sirolimus-Eluting Stents: Results From a Large Prospective Multicenter Registry STENT Group J. Am. Coll. Cardiol., September 25, 2007; 50(13): 1214 - 1222. [Abstract] [Full Text] [PDF] |
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A. Colombo and A. Chieffo Drug-Eluting Stent Update 2007: Part III: Technique and Unapproved/Unsettled Indications (Left Main, Bifurcations, Chronic Total Occlusions, Small Vessels and Long Lesions, Saphenous Vein Grafts, Acute Myocardial Infarctions, and Multivessel Disease) Circulation, September 18, 2007; 116(12): 1424 - 1432. [Full Text] [PDF] |
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F. Airoldi, A. Colombo, N. Morici, A. Latib, J. Cosgrave, L. Buellesfeld, E. Bonizzoni, M. Carlino, U. Gerckens, C. Godino, et al. Incidence and Predictors of Drug-Eluting Stent Thrombosis During and After Discontinuation of Thienopyridine Treatment Circulation, August 14, 2007; 116(7): 745 - 754. [Abstract] [Full Text] [PDF] |
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P. Jimenez-Quevedo, M. Sabate, D. J. Angiolillo, F. Alfonso, R. Hernandez-Antolin, M. SanMartin, J. A. Gomez-Hospital, C. Banuelos, J. Escaned, R. Moreno, et al. Long-term clinical benefit of sirolimus-eluting stent implantation in diabetic patients with de novo coronary stenoses: long-term results of the DIABETES trial Eur. Heart J., August 2, 2007; 28(16): 1946 - 1952. [Abstract] [Full Text] [PDF] |
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C. Bode and M. Zehender The use of antiplatelet agents following percutaneous coronary intervention: focus on late stent thrombosis Eur. Heart J. Suppl., August 1, 2007; 9(suppl_D): D10 - D19. [Abstract] [Full Text] [PDF] |
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J. Daemen and P. W. Serruys Drug-Eluting Stent Update 2007: Part I: A Survey of Current and Future Generation Drug-Eluting Stents: Meaningful Advances or More of the Same? Circulation, July 17, 2007; 116(3): 316 - 328. [Full Text] [PDF] |
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F. Ribichini, M. Joner, V. Ferrero, A. V. Finn, J. Crimins, G. Nakazawa, E. Acampado, F. D. Kolodgie, C. Vassanelli, and R. Virmani Effects of Oral Prednisone After Stenting in a Rabbit Model of Established Atherosclerosis J. Am. Coll. Cardiol., July 10, 2007; 50(2): 176 - 185. [Abstract] [Full Text] [PDF] |
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A. Chieffo, S. J. Park, M. Valgimigli, Y. H. Kim, J. Daemen, I. Sheiban, A. Truffa, M. Montorfano, F. Airoldi, G. Sangiorgi, et al. Favorable Long-Term Outcome After Drug-Eluting Stent Implantation in Nonbifurcation Lesions That Involve Unprotected Left Main Coronary Artery: A Multicenter Registry Circulation, July 10, 2007; 116(2): 158 - 162. [Abstract] [Full Text] [PDF] |
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R. Moreno, C. Fernandez, A. Sanchez-Recalde, G. Galeote, L. Calvo, F. Alfonso, R. Hernandez, R. Sanchez-Aquino, D. J. Angiolillo, S. Villarreal, et al. Clinical impact of in-stent late loss after drug-eluting coronary stent implantation Eur. Heart J., July 1, 2007; 28(13): 1583 - 1591. [Abstract] [Full Text] [PDF] |
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N. J. Weissman, S. G. Ellis, E. Grube, K. D. Dawkins, J. D. Greenberg, T. Mann, L. A. Cannon, P. A. Cambier, S. Fernandez, G. S. Mintz, et al. Effect of the polymer-based, paclitaxel-eluting TAXUS Express stent on vascular tissue responses: a volumetric intravascular ultrasound integrated analysis from the TAXUS IV, V, and VI trials Eur. Heart J., July 1, 2007; 28(13): 1574 - 1582. [Abstract] [Full Text] [PDF] |
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A. Marzocchi, F. Saia, G. Piovaccari, A. Manari, E. Aurier, A. Benassi, A. Cremonesi, G. Percoco, E. Varani, P. Magnavacchi, et al. Long-Term Safety and Efficacy of Drug-Eluting Stents: Two-Year Results of the REAL (REgistro AngiopLastiche dell'Emilia Romagna) Multicenter Registry Circulation, June 26, 2007; 115(25): 3181 - 3188. [Abstract] [Full Text] [PDF] |
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G. W. Stone, S. G. Ellis, A. Colombo, K. D. Dawkins, E. Grube, D. E. Cutlip, M. Friedman, D. S. Baim, and J. Koglin Offsetting Impact of Thrombosis and Restenosis on the Occurrence of Death and Myocardial Infarction After Paclitaxel-Eluting and Bare Metal Stent Implantation Circulation, June 5, 2007; 115(22): 2842 - 2847. [Abstract] [Full Text] [PDF] |
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E. Camenzind, P. G. Steg, and W. Wijns A Cause for Concern Circulation, March 20, 2007; 115(11): 1440 - 1455. [Full Text] [PDF] |
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S. G. Ellis, A. Colombo, E. Grube, J. Popma, J. Koglin, K. D. Dawkins, and G. W. Stone Incidence, Timing, and Correlates of Stent Thrombosis With the Polymeric Paclitaxel Drug-Eluting Stent: A TAXUS II, IV, V, and VI Meta-Analysis of 3,445 Patients Followed for Up to 3 Years J. Am. Coll. Cardiol., March 13, 2007; 49(10): 1043 - 1051. [Abstract] [Full Text] [PDF] |
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G. W. Stone, J. W. Moses, S. G. Ellis, J. Schofer, K. D. Dawkins, M.-C. Morice, A. Colombo, E. Schampaert, E. Grube, A. J. Kirtane, et al. Safety and Efficacy of Sirolimus- and Paclitaxel-Eluting Coronary Stents N. Engl. J. Med., March 8, 2007; 356(10): 998 - 1008. [Abstract] [Full Text] [PDF] |
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L. Mauri, W.-h. Hsieh, J. M. Massaro, K. K.L. Ho, R. D'Agostino, and D. E. Cutlip Stent Thrombosis in Randomized Clinical Trials of Drug-Eluting Stents N. Engl. J. Med., March 8, 2007; 356(10): 1020 - 1029. [Abstract] [Full Text] [PDF] |
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M. Pfisterer, H. P. Brunner-La Rocca, P. T. Buser, P. Rickenbacher, P. Hunziker, C. Mueller, R. Jeger, F. Bader, S. Osswald, C. Kaiser, et al. Late Clinical Events After Clopidogrel Discontinuation May Limit the Benefit of Drug-Eluting Stents: An Observational Study of Drug-Eluting Versus Bare-Metal Stents J. Am. Coll. Cardiol., November 1, 2006; (2006) j.jacc.2006.10.026v1. [Abstract] [Full Text] [PDF] |
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M. J. Eisenberg Drug-Eluting Stents: The Price Is Not Right Circulation, October 17, 2006; 114(16): 1745 - 1754. [Full Text] [PDF] |
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F. Saia, G. Piovaccari, A. Manari, A. Santarelli, A. Benassi, E. Aurier, P. Sangiorgio, F. Tarantino, G. Geraci, G. Vecchi, et al. Clinical Outcomes for Sirolimus-Eluting Stents and Polymer-Coated Paclitaxel-Eluting Stents in Daily Practice: Results From a Large Multicenter Registry J. Am. Coll. Cardiol., October 3, 2006; 48(7): 1312 - 1318. [Abstract] [Full Text] [PDF] |
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H. Futamatsu, M. Sabate, D. J. Angiolillo, P. Jimenez-Quevedo, C. Corros, K. Morikawa-Futamatsu, F. Alfonso, J. Jiang, P. Cervinka, R. Hernandez-Antolin, et al. Characterization of Plaque Prolapse After Drug-Eluting Stent Implantation in Diabetic Patients: A Three-Dimensional Volumetric Intravascular Ultrasound Outcome Study J. Am. Coll. Cardiol., September 19, 2006; 48(6): 1139 - 1145. [Abstract] [Full Text] [PDF] |
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G. J. Laarman, M. J. Suttorp, M. T. Dirksen, L. van Heerebeek, F. Kiemeneij, T. Slagboom, L. R. van der Wieken, J. G.P. Tijssen, B. J. Rensing, and M. Patterson Paclitaxel-Eluting versus Uncoated Stents in Primary Percutaneous Coronary Intervention N. Engl. J. Med., September 14, 2006; 355(11): 1105 - 1113. [Abstract] [Full Text] [PDF] |
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G. S. Mintz and N. J. Weissman Intravascular Ultrasound in the Drug-Eluting Stent Era J. Am. Coll. Cardiol., August 1, 2006; 48(3): 421 - 429. [Abstract] [Full Text] [PDF] |
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B. E. Stahli, G. G. Camici, J. Steffel, A. Akhmedov, K. Shojaati, M. Graber, T. F. Luscher, and F. C. Tanner Paclitaxel Enhances Thrombin-Induced Endothelial Tissue Factor Expression via c-Jun Terminal NH2 Kinase Activation Circ. Res., July 21, 2006; 99(2): 149 - 155. [Abstract] [Full Text] [PDF] |
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S. Elezi, A. Dibra, U. Folkerts, J. Mehilli, S. Heigl, A. Schomig, and A. Kastrati Cost Analysis From Two Randomized Trials of Sirolimus-Eluting Stents Versus Paclitaxel-Eluting Stents in High-Risk Patients With Coronary Artery Disease J. Am. Coll. Cardiol., July 18, 2006; 48(2): 262 - 267. [Abstract] [Full Text] [PDF] |
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F. Liistro, M. Fineschi, P. Angioli, G. Sinicropi, G. Falsini, T. Gori, K. Ducci, A. Bravi, and L. Bolognese Effectiveness and Safety of Sirolimus Stent Implantation for Coronary In-Stent Restenosis: The TRUE (Tuscany Registry of Sirolimus for Unselected In-Stent Restenosis) Registry J. Am. Coll. Cardiol., July 18, 2006; 48(2): 270 - 275. [Abstract] [Full Text] [PDF] |
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J. Cosgrave, G. Melzi, G. G.L. Biondi-Zoccai, F. Airoldi, A. Chieffo, G. M. Sangiorgi, M. Montorfano, I. Michev, M. Carlino, E. Bonizzoni, et al. Drug-Eluting Stent Restenosis: The Pattern Predicts the Outcome J. Am. Coll. Cardiol., June 20, 2006; 47(12): 2399 - 2404. [Abstract] [Full Text] [PDF] |
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P. W. Serruys Fourth Annual American College of Cardiology International Lecture: A Journey in the Interventional Field J. Am. Coll. Cardiol., May 2, 2006; 47(9): 1754 - 1768. [Full Text] [PDF] |
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W. J. Gomes and E. Buffolo Coronary stenting and inflammation: implications for further surgical and medical treatment. Ann. Thorac. Surg., May 1, 2006; 81(5): 1918 - 1925. [Abstract] [Full Text] [PDF] |
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C Roiron, P Sanchez, A Bouzamondo, P Lechat, and G Montalescot Drug eluting stents: an updated meta-analysis of randomised controlled trials Heart, May 1, 2006; 92(5): 641 - 649. [Abstract] [Full Text] [PDF] |
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C Stettler, S Allemann, M Egger, S Windecker, B Meier, and P Diem Efficacy of drug eluting stents in patients with and without diabetes mellitus: indirect comparison of controlled trials Heart, May 1, 2006; 92(5): 650 - 657. [Abstract] [Full Text] [PDF] |
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A. E. Rodriguez, J. F. Granada, M. Rodriguez-Alemparte, C. F. Vigo, J. Delgado, C. Fernandez-Pereira, A. Pocovi, A. M. Rodriguez-Granillo, D. Schulz, A. E. Raizner, et al. Oral Rapamycin After Coronary Bare-Metal Stent Implantation to Prevent Restenosis: The Prospective, Randomized Oral Rapamycin in Argentina (ORAR II) Study J. Am. Coll. Cardiol., April 18, 2006; 47(8): 1522 - 1529. [Abstract] [Full Text] [PDF] |
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G. Weisz, M. B. Leon, D. R. Holmes Jr, D. J. Kereiakes, M. R. Clark, B. M. Cohen, S. G. Ellis, P. Coleman, C. Hill, C. Shi, et al. Two-Year Outcomes After Sirolimus-Eluting Stent Implantation: Results From the Sirolimus-Eluting Stent in de Novo Native Coronary Lesions (SIRIUS) Trial J. Am. Coll. Cardiol., April 4, 2006; 47(7): 1350 - 1355. [Abstract] [Full Text] [PDF] |
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G. W. Stone, S. G. Ellis, C. D. O'Shaughnessy, S. L. Martin, L. Satler, T. McGarry, M. A. Turco, D. J. Kereiakes, L. Kelley, J. J. Popma, et al. Paclitaxel-Eluting Stents vs Vascular Brachytherapy for In-Stent Restenosis Within Bare-Metal Stents: The TAXUS V ISR Randomized Trial JAMA, March 15, 2006; 295(11): 1253 - 1263. [Abstract] [Full Text] [PDF] |
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S. G. Raja Drug-Eluting Stents and the Future of Coronary Artery Bypass Surgery: Facts and Fiction Ann. Thorac. Surg., March 1, 2006; 81(3): 1162 - 1171. [Abstract] [Full Text] [PDF] |
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M.-C. Morice, A. Colombo, B. Meier, P. Serruys, C. Tamburino, G. Guagliumi, E. Sousa, H.-P. Stoll, and for the REALITY Trial Investigators Sirolimus- vs Paclitaxel-Eluting Stents in De Novo Coronary Artery Lesions: The REALITY Trial: A Randomized Controlled Trial JAMA, February 22, 2006; 295(8): 895 - 904. [Abstract] [Full Text] [PDF] |
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S. J. Brener Wish List and REALITY: Choice of Stents and End Points for Treatment of De Novo Coronary Artery Lesions JAMA, February 22, 2006; 295(8): 937 - 938. [Full Text] [PDF] |
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R. Wessely, A. Schomig, and A. Kastrati Sirolimus and Paclitaxel on Polymer-Based Drug-Eluting Stents: Similar But Different J. Am. Coll. Cardiol., February 21, 2006; 47(4): 708 - 714. [Abstract] [Full Text] [PDF] |
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